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LEVETIRACETAM TEVA 100 MG/ML ORAL SOLUTION

Active substance(s): LEVETIRACETAM

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TEVA UK Ref:

231-30-64216-C LEA LEVETIRACETAM 100mg/ml SOL TUK
LEVETIRACETAM TEVA 100 mg/ml
ORAL SOLUTION
PACKAGE LEAFLET:
INFORMATION FOR THE USER

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
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Version:

1

12 May 2014

Levetiracetam Teva oral solution also contains
maltitol. If you have been told by your doctor that
you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.

3

How to take Levetiracetam Teva 100 mg/ml
Oral Solution

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure. Levetiracetam Teva
must be taken twice a day, once in the morning and
once in the evening, at about the same time each
day. Take the oral solution following your doctor’s
instructions.

Monotherapy
Dose in adults and adolescents aged 16 years and
above:
General dose: between 10 ml (1,000 mg) and 30 ml
WHAT IS IN THIS LEAFLET:
(3,000 mg) each day, divided in 2 intakes per day.
What Levetiracetam Teva 100 mg/ml oral solution When you first start taking Levetiracetam Teva,
is and what it is used for
your doctor will prescribe you a lower dose for 2
What you need to know before you take
weeks before giving you the lowest general dose.
Levetiracetam Teva 100 mg/ml oral solution
How to take Levetiracetam Teva 100 mg/ml oral Add-on therapy
Dose in adults and adolescents aged 12 to 17 years
solution
weighing 50 kg or more:
Possible side effects
How to store Levetiracetam Teva 100 mg/ml oral General dose: between 10 ml (1,000 mg) and 30 ml
(3,000 mg) each day, divided in 2 intakes per day.
solution
Contents of the pack and other information
Dose in infants aged 6 to 23 months, children aged

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What Levetiracetam Teva 100 mg/ml Oral
Solution is and what it is used for

Levetiracetam Teva 100 mg/ml oral solution is an
antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Levetiracetam Teva is used:
• on its own in adults and adolescents from 16
years of age with newly diagnosed epilepsy, to
treat partial onset seizures with or without
secondary generalisation
• as an add-on to other antiepileptic medicines
to treat:
• partial onset seizures with or without
generalisation in adults, adolescents, children
and infants from one month of age
• myoclonic seizures in adults and adolescents
from 12 years of age with juvenile myoclonic
epilepsy
• primary generalised tonic-clonic seizures in
adults and adolescents from 12 years of age
with idiopathic generalised epilepsy.

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2 to 11 years and adolescents aged 12 to 17 years,
weighing less than 50 kg:
Your doctor will prescribe the most appropriate
pharmaceutical form of Levetiracetam according to
the age, weight and dose.
General dose: between 0.2 ml (20 mg) and 0.6 ml
(60 mg) per kg bodyweight each day, divided in 2
intakes per day. The exact quantity of oral solution
formulation should be measured using the syringe
(provided in the cardboard box) and then emptying
the contents of the syringe into either a glass of
water or baby’s bottle.
Weight
Starting dose:
Maximum dose:
0.1 ml/kg twice daily 0.3 ml/kg twice daily
6 kg

0.6 ml twice daily

1.8 ml twice daily

8 kg

0.8 ml twice daily

2.4 ml twice daily

10 kg

1 ml twice daily

3 ml twice daily

15 kg

1.5 ml twice daily

4.5 ml twice daily

20 kg

2 ml twice daily

6 ml twice daily

25 kg

2.5 ml twice daily

7.5 ml twice daily

What you need to know before you take
Levetiracetam Teva 100 mg/ml Oral Solution From 50 kg 5 ml twice daily

15 ml twice daily

Do not take Levetiracetam Teva
If you are allergic (hypersensitive) to levetiracetam
or any of the other ingredients of this medicine
(listed in section 6).

Children 25 kg or less should start the treatment
with Levetiracetam Teva 100 mg/ml oral solution.
Dose in children and adolescents 50 kg or more is
the same as in adults

Warnings and precautions
Talk to your doctor or pharmacist before taking this
medicine:
• if you suffer from kidney problems, follow your
doctor’s instructions. He/she may decide if your
dose should be adjusted.
• if you notice any slow down in the growth or
unexpected puberty development of your child,
please contact your doctor
• if you notice an increase in seizure severity (e.g.
increased number), please contact your doctor
• a small number of people being treated with
anti-epileptics such as Levetiracetam Teva have
had thoughts of harming or killing themselves. If
you have any symptoms of depression and/or
suicidal ideation, please contact your doctor.

Dose in infants aged 1 month to less than 6 months:
General dose: between 0.14 ml (14 mg) and 0.42 ml
(42 mg) per kg bodyweight each day, divided in 2
intakes per day. The exact quantity of oral solution
formulation should be measured using the syringe
provided in the cardboard box and then emptying
the contents of the syringe into either a glass of
water or baby’s bottle.

Other medicines and Levetiracetam Teva
Please tell your doctor or pharmacist if you are
taking, have recently taken or might take any other
medicines.

Method of administration:
Levetiracetam Teva oral solution may be diluted in a
glass of water or baby’s bottle.

Weight Starting dose:
0.07 ml/kg twice daily

Maximum dose:
0.21 ml/kg twice daily

4 kg

0.3 ml twice daily

0.85 ml twice daily

5 kg

0.35 ml twice daily

1.05 ml twice daily

6 kg

0.45 ml twice daily

1.25 ml twice daily

7 kg

0.5 ml twice daily

1.5 ml twice daily

Instructions for use:

Levetiracetam Teva with food, drink and alcohol
You may take Levetiracetam Teva with or without
food. As a safety precaution, do not take
Levetiracetam Teva with alcohol.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine. Levetiracetam Teva should not
be used during pregnancy unless clearly
necessary. A risk of birth defects for your unborn
child cannot be completely excluded.
Levetiracetam Teva has shown unwanted
reproductive effects in animal studies at dose
levels higher than you would need to control your
seizures. Breast-feeding is not recommended
during treatment. If you are pregnant, think you may
be pregnant, or are planning to have a baby ask
your doctor for advice before taking this medicine.
Driving and using machines
Levetiracetam Teva may impair your ability to drive
or operate any tools or machinery, as
Levetiracetam Teva may make you feel sleepy. This
is more likely at the beginning of treatment or after
an increase in the dose. You should not drive or use
machines until it is established that your ability to
perform such activities is not affected.
Levetiracetam Teva 100 mg/ml oral solution
contains methyl parahydroxybenzoate, propyl
parahydroxybenzoate and maltitol
Levetiracetam Teva oral solution includes methyl
parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216) which may cause
allergic reactions (possibly delayed).

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• Open the bottle: press the
cap and turn it
anticlockwise (figure 1).
• Insert the syringe adaptor
into the bottle neck (figure
2). Ensure it is well fixed.

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• Take the syringe and put it
in the adaptor opening
(figure 2).
• Turn the bottle upside down
(figure 3).
• Fill the syringe with a small
amount of solution by
pulling the piston down
(figure 4), then push the
piston upward in order to
remove any possible
bubbles (figure 5). Pull the
piston down to the
graduation mark
corresponding to the
quantity in millilitres (ml)
prescribed by your doctor
(figure 6).

TEVA UK Ref:

231-30-64216-C LEA LEVETIRACETAM 100mg/ml SOL TUK
Version:

1

12 May 2014

• Turn the bottle the right way • amnesia (loss of memory), memory impairment
(forgetfulness), abnormal coordination/ataxia
up.
(impaired coordinated movements), paraesthesia
(tingling), disturbance in attention (loss of
• Remove the syringe from
concentration);
the adaptor.
• diplopia (double vision), vision blurred;
6 • Empty the contents of the • liver function test abnormal;
• hair loss, eczema, pruritus;
syringe into a glass of
• muscle weakness, myalgia (muscle pain);
water or baby’s bottle by
• injury.
pushing the piston to the
bottom (figure 7).
Rare: may affect 1 to 10 users in 10,000
• Drink the whole contents of • infection;
• decreased number of all blood cell types;
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the glass / baby’s bottle.
• suicide, personality disorders (behavioural
problems), thinking abnormal (slow thinking,
• Close the bottle with the
unable to concentrate);
plastic screw cap.
• uncontrollable muscle spasms affecting the
head, torso and limbs, difficulty in controlling
• Wash the syringe with
movements, hyperkinesia (hyperactivity);
water only (figure 8).
• hepatitis
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• Low blood levels of sodium which can cause
Duration of treatment:
tiredness and confusion, muscle twitching, fits or
Levetiracetam Teva is used as a chronic treatment.
coma.
You should continue Levetiracetam Teva treatment
for as long as your doctor has told you.

Reporting of side effects
If you take more Levetiracetam Teva than you should: If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
The possible side effects of an overdose of
not listed in this leaflet. You can also report side
Levetiracetam Teva are sleepiness, agitation,
effects directly via the Yellow Card Scheme at:
aggression, decrease of alertness, inhibition of
www.mhra.gov.uk/yellowcard.
breathing and coma.
Contact your doctor if you took more Levetiracetam By reporting side effects you can help provide more
Teva than you should. Your doctor will establish the information on the safety of this medicine.
best possible treatment for an overdose.
How to store Levetiracetam Teva

5

100 mg/ml Oral Solution
If you forget to take Levetiracetam Teva:
Contact your doctor if you have missed one or more Keep out of the sight and reach of children.
doses.
Do not use this medicine after the expiry date
Do not take a double dose to make up for a
stated on the cardboard box and bottle after EXP.
forgotten dose.
The expiry date refers to the last day of the month.
If you stop taking Levetiracetam Teva:
Do not use after 7 months of first opening the bottle.
Do not stop your treatment without your doctor’s
Due to sensitivity to light, store in the original
advice as this could increase your seizures.
container.
If stopping treatment, as with other antiepileptic
medicines, Levetiracetam Teva should be
Store in an upright position.
discontinued gradually to avoid an increase of
seizures.
Do not throw away any medicines via wastewater
Should your doctor decide to stop your Levetiracetam or household waste. Ask your pharmacist how to
Teva treatment, he/she will instruct you about the
throw away medicines you no longer use. These
gradual withdrawal of Levetiracetam Teva.
measures will help to protect the environment.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
You should go to Accident and Emergency
immediately if you experience symptoms of;
• serious allergic reaction that may begin with a
skin rash, which may form blisters and looks like
small targets (central dark spots surrounded by a
paler area, with a dark ring around the edge)
(erythema multiforme)
• a widespread rash with blisters and peeling skin,
particularly around the mouth, nose, eyes and
genitals (Stevens-Johnson syndrome)
• a more severe form causing skin peeling in more
than 30% of the body surface (toxic epidermal
necrolysis)
• a rash, fever, inflammation of internal organ and
blood abnormalities including an increase in
white blood cells (DRESS syndrome).
You should contact your doctor immediately if you
experience symptoms of severe abdominal and
back pain accompanied with feeling very unwell
(pancreatitis) or hepatic failure.
You should see your doctor immediately if you
experience depression, emotional instability/mood
swings, or suicidal thoughts or behaviour.

6

Contents of the pack and other information

What Levetiracetam Teva 100 mg/ml oral solution
contains
The active substance is levetiracetam. Each ml
contains 100 mg of levetiracetam.
The other ingredients are:
Sodium citrate
Citric acid monohydrate
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Ammonium glycyrrhizate
Glycerol (E422)
Maltitol liquid (E965)
Acesulfame potassium (E950)
Grapefruit flavour
Purified water.
What Levetiracetam Teva 100 mg/ml oral solution
looks like and contents of the pack
Levetiracetam Teva 100 mg/ml oral solution is a
clear liquid.
50 ml solution (sample pack) in an amber glass
bottle with a white child resistant closure in a
cardboard box also containing a 1 ml oral syringe
(graduated every 0.05 ml) and an adaptor for the
syringe.
150 ml solution in an amber glass bottle with a white
child resistant closure (for infants aged 1 month to
less than 6 months) in a cardboard box also
containing a 1 ml oral syringe (graduated every
0.05 ml) and an adaptor for the syringe.

You should also seek medical attention if you
experience a hypersensitivity reaction (for example
itching, rash, hives, difficulty breathing).
150 ml solution in an amber glass bottle with a white
child resistant closure (for infants and young
Some of the side effects like sleepiness, tiredness children aged from 6 months to less than 4 years) in
and dizziness may be more common at the
a cardboard box also containing a 3 ml oral syringe
beginning of the treatment or at dose increase.
(graduated every 0.1 ml) and an adaptor for the
These effects should however decrease over time. syringe.
Very common: may affect more than 1 in 10 people 300 ml solution in an amber glass bottle with a white
• nasopharyngitis (cough, sore throat, runny nose child resistant closure (for children aged 4 years
and fever)
and above, adolescents and adults) in a cardboard
• somnolence (sleepiness); headache.
box also containing a 10 ml oral syringe (graduated
Common: may affect up to 1 in 10 people
• anorexia (loss of appetite);
• hostility or aggression, anxiety, insomnia,
nervousness or irritability;
• convulsion, balance disorder (equilibrium
disorder), dizziness (sensation of unsteadiness),
lethargy, tremor (involuntary trembling);
• vertigo (sensation of rotation);
• cough;
• abdominal pain, diarrhoea, dyspepsia
(indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (tiredness).
Uncommon: may affect 1 to 10 users in 1000
• decreased number of blood platelets, decreased
number of white blood cells;
• weight decrease, weight increase;
• suicide attempt, mental disorder, abnormal
behaviour, hallucination, anger, confusion, panic
attack, agitation;

every 0.25 ml) and an adaptor for the syringe.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva UK Limited,
Eastbourne,
BN22 9AG,
United Kingdom.
Manufacturer
Bluepharma Indústria Farmacêutica, S.A.,
S. Martinho de Bispo,
3045-016 Coimbra,
Portugal.
This leaflet was last revised in 03/2014
PL 00289/1703
64216-C

154 x 420

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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